Application 018030

Type: NDA
Sponsor: B BRAUN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	2.5GM/100ML;450MG/100ML	No	No
002	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;450MG/100ML	No	No
003	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;330MG/100ML	No	No
004	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;200MG/100ML	No	No
005	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;110MG/100ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
N018030-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982
N018030-002	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982
N018030-003	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	Approved before 1982
N018030-004	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982
N018030-005	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION	Approved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 3 of 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2024-05-31 18:47 UTC	2024-05	N018030-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018030-002	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018030-003	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018030-004	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018030-005	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018030-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018030-002	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018030-003	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018030-004	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018030-005	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018030-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018030-002	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018030-003	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018030-004	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018030-005	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018030-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018030-002	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018030-003	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018030-004	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018030-005	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018030-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018030-002	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018030-003	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018030-004	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018030-005	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018030-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018030-002	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018030-003	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018030-004	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018030-005	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018030-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018030-002	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018030-003	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018030-004	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018030-005	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018030-001	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	2.5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018030-002	DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5GM/100ML;450MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018030-003	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	5GM/100ML;330MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018030-004	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	5GM/100ML;200MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018030-005	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	5GM/100ML;110MG/100ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Application 018030

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

Reported adverse events (FAERS/openFDA)#